Clinical trial · Interventional
Evaluation of a Multi-professional Breathlessness Service for Patients With Breathlessness Due to Any Advanced Disease
Randomised Controlled Trial Testing the Effectiveness of a New Multi-professional Breathlessness sErvice for Patients With Any Advanced diSease Against Usual Care (BreathEase)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breathlessness is a common and distressing symptom in patients with advanced diseases like cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or lung fibrosis, which broadly impacts on patients' quality of life and may result in high burden for carers. This single-blinded randomized controlled fast track trial evaluates the effectiveness of a multi-professional breathlessness service in patients with advanced and chronic diseases. The intervention group will get immediate access to the breathlessness service whereas the control group will receive standard care and get access to the service after a waiting time of eight weeks. Primary endpoints are mastery of breathlessness and quality of life, measured with the CRQ (Chronic Respiratory Questionnaire) as well as the reduction of symptom burden of patients and burden of carers. The evaluation of the cost effectiveness of the breathlessness service from the perspective of the German health system is a further study aim.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breathlessness | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chronic Heart Failure | — | UNRESOLVED | — |
| COPD | — | UNRESOLVED | — |
| Interstitial Lung Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Delayed MBS Intervention | Other | — | UNRESOLVED |
| Multi-professional breathlessness service (MBS) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Patients randomised to the intervention group will get immediate access to the Multi-professional breathlessness service (MBS).
- interventionNames
- Other: Multi-professional breathlessness service (MBS)
- type
- OTHER
- label
- Control Group
- description
- Patients randomised to the control group will get delayed MBS intervention. They will receive standard care and get access to the service after a waiting time of eight weeks.
- interventionNames
- Other: Delayed MBS Intervention
Primary outcomes (4)
- measure
- Mastery of breathlessness (CRQ mastery subscale)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients affected by breathlessness due to any advanced life-limiting and progressive disease, despite treatment of the underlying condition and * Patients capable (in a cognitive and functional manner) to participate in the intervention including outpatient clinic and physiotherapist visits as well as self- management * If patients are suffering from acute exacerbations of the underlying conditions, they are put on a waiting list for two to four weeks and are then entered into the trial. Exclusion Criteria: * Patients suffering from breathlessness due to chronic hyperventilation syndrome, asthma or any other unknown cause * Cancer patients under concurrent initial or full dose systemic treatment or radiotherapy (except on maintenance therapy) * Patients participating in any trial targeting the treatment of underlying conditions/ illness
References
Publications (1)
- DERIVEDSchunk M, Le L, Syunyaeva Z, Haberland B, Tanzler S, Mansmann U, Schwarzkopf L, Seidl H, Streitwieser S, Hofmann M, Muller T, Weiss T, Morawietz P, Rehfuess EA, Huber RM, Berger U, Bausewein C. Effectiveness of a specialised breathlessness service for patients with advanced disease in Germany: a pragmatic fast-track randomised controlled trial (BreathEase). Eur Respir J. 2021 Aug 26;58(2):2002139. doi: 10.1183/13993003.02139-2020. Print 2021 Aug. PMID 33509957